CompletedNot Applicable

COVID19 Vaccine in SOT Adult Recipients

Italy364 participantsStarted 2021-10-01

Plain-language summary

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints: * T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status * Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination * T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity * Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age \> 18 years * Patient's written informed consent Exclusion Criteria: * Lung transplant being performed in the previous 6 months * Liver transplant being performed in the previous 3 months

What they're measuring

Safety and reactogenicity

Timeframe: 365 days

Trial details

NCT IDNCT05116748

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

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